SureSigns VS4
SureSigns VS4 U.S.Gov NBP, SPO2
9manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Philips Medical Systems Hsg |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Record published | 2019-04-17 |
| Record revised | 2026-02-11 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 40 °C; Storage environment temperature -4 to 104 °F; Storage environment atmospheric pressure 70 to 101 KiloPascal; Storage environment humidity 15 to 80 % RH |
| Distribution end date | 2021-01-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 863283 | In distribution | |
| 863379 | Withdrawn | |
| 863283 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 1397 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 518 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 12543 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 3177 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 21857 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 12719 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 61522 |
| Philips North America LLC | UDI-DI | 2019-04-19 | Class II | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. | 366 |
| Philips North America LLC | UDI-DI | 2018-07-13 | Class II | Labeling design | Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-disch | VM 96,324 Units; VS 110,424 Units; VSV 691 Units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.